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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

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SIEMENS HEALTHCARE GMBH UROSKOP OMNIA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Model Number 10094910
Device Problem Fire (1245)
Patient Problem Sore Throat (2396)
Event Date 09/04/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter name and address:: a customer contact name was provided in japanese characters and was not translated for reporting.The customer facility phone number is +0584813341.Initial corrective actions/preventive actions implemented by the manufacturer: the system was taken out of use at the affected site.With the currently available information no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the cause for the fire has not been identified yet.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.
 
Event Description
When the room was vacant after an examination the fire alarm in the examination room went off.Smoke and fire were emitted from the system.The fire was extinguished by staff.At first it was communicated that no injury occurred.However, additional information was received stating the radiology technicians involved in extinguishing the fire complained of sore throats.There was no patient involvement.The system was taken out of use.It is currently unclear what the cause for the fire was.The issue is reported because the circumstances are still unclear, and a fire was communicated.In case of a fire a serious injury cannot be excluded.Further information was requested for investigation.
 
Manufacturer Narrative
The investigation of the reported event started shortly following the incident by the siemens local service organization, the local police and fire departments.It was communicated that on (b)(6) 2023, the police had seized the affected m2 electronic box, where the four motor controllers were mounted.The fire department suspected the motor controller u160 to be the origin of the fire.The uroskop omnia system was dismantled and brought to a local warehouse for further analysis.Circuit diagrams of the controller u160 were provided by the manufacturer lenze to the investigators.The investigation by the local fire department concluded that the fire had caused the most damage to the back side of the resistor r5 of the u160 controller.Upon completion of local investigations by the police and the fire departments, the uroskop omnia system was sent to kemnath, germany, for further investigation.The system was inspected by siemens product and electronic experts from kemnath.All cabling at the input and the output side of the u160, as well as winding of the motor that is connected to the u160 was checked via visual inspection and electrical measurements.Defective cablings and short circuits inside the motor and all other peripherical causes were excluded as reason for the fire.The material testing laboratory reviewed the circuit diagram of the u160 for possible causes of overheating.Optical assessment of the u160 controller confirmed that the resistor r5 was thermally destroyed.The material testing laboratory identified that the origin of the thermal energy that led to the fire in the m2 electronics assembly was the resistor r5.The only available log files are dated one week prior to the incident.No traces of unusual user workflows could be found.The cause for the resistor to overheat is still under investigation.
 
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Brand Name
UROSKOP OMNIA
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemensstrasse 1
or rittigfeld 1
forchheim 91301
GM  91301
Manufacturer (Section G)
SIEMENS HEALTHINEERS AG
siemensstrasse 1
or rittigfeld 1
forchheim 91301
GM   91301
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
malvern, PA 19355
4843234197
MDR Report Key17716893
MDR Text Key323035327
Report Number3004977335-2023-00111
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10094910
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/04/2023
Initial Date FDA Received09/10/2023
Supplement Dates Manufacturer Received03/04/2024
Supplement Dates FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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